ISO 13485 Audit Checklist Document Template


AN EASY WAY TO GET YOUR ISO 13485 audit checklist document template DONE IN ONE SHOT!

  • Need to Complete your GLP/GMP/ISO/QMS/GDPR/HIPAA audit on time?
  • Want to be sure your inspection will meet all relevant regulatory requirements?
  • Do not have enough budget to hire a consulting company to complete your audit?


Be in full compliance with the GLP/GMP/ISO/QMS/GDPR/HIPAA regulations in a short time and with minor costs.


This ISO 13485 QMS audit checklist template provides you all the topics covered in the ISO 13485:2016 standard, relevant sections numbers, questions, and instructions for conducting an internal/self and/or mock audit towards or external ISO 13485 Quality Management System inspection in a detailed and well-organized checklist template.

 About this template

  • Versatile & easy to use ISO 13485 audit checklist document template
  • Immediate download
  • MS word, 71 pages ready to use ISO 13485 audit checklist document template
  • Clear instructions for use
  • Fits for FDA/Eu./ICH/GLP/GMP/ISO/QMS/GDPR/HIPAA regulations
  • Fit to Pharma/Medical/E-Health/Supplements and other industries

Your final audit report can be reviewed by our consultants- Optional


Understand how our audits checklists template will support you best:

  • Best methodology and practice that fits your industry, products and regulatory requirements
  • Have a template that is being used daily by our consultants in international FDA/Eu/ISO audits
  • Improve your regulatory inspection capabilities
  • Prepare your audit, based on smart & easy to use templates
  • Immediate access to downloads
  • Be independent and keep professionalism in-house.

In Addition

  • Get access to hundreds of templates for your future needs
  • Get full support and advice for your regulatory needs
  • Customized documents writing
  • Review your final document before final approval

Bio-Chem is here to support all your current and future regulatory and documentation needs!

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